Tesis

Perbedaan Efektivitas dan Keamanan Terapi Tekanan Jalan Napas Positif Berkelanjutan Dibandingkan Dengan Kanul Nasal Aliran Tinggi Lembab dan Hangat Pada Bayi Prematur (Sejak Lahir) yang Mengalami Sesak Napas Derajat Sedang = The Difference of Safety and Effectivity of Nasal Continuous Positive Airway Pressure and Heated Humidified High Flow Nasal Cannula in Premature Baby (Since Born) with Moderate Respiratory Distress.

Sesak napas bayi baru lahir merupakan morbiditas tersering pada bayi prematur < 35 minggu. Sesak napas harus ditangani secepatnya dengan pemberian tekanan jalan napas positif. Sampai saat ini, nCPAP merupakan pilihan pertama terapi ventilasi non-invasive untuk bayi prematur. Walaupun efektif, nCPAP sering memberikan efek samping berupa trauma hidung. Heated humidified high flow nasal cannulae merupakan metode terapi oksigen beraliran tinggi yang tanpa sengaja mampu memberikan tekanan jalan napas positif, namun keamanan dan efektifitasanya masih belum banyak diteliti. Mengetahui efektifitas dan keamanaan HHHFN dibanding nCPAP pada bayi prematur usia > 28 minggu dan < 35 minggu yang mengalami sesak napas derajat sedang. Penelitian ini merupakan uji klinis non-inferioritas, acak, tidak tersamar yang membandingkan HHHFN dan nCPAP pada bayi prematur usia yang mengalami sesak napas sejak dari kamar bersalin Tidak ada perbedaan insiden intubasi endotrakeal pada pemakaian < 72 jam HHHFN 20% dibanding nCPAP 18% (p = 0,799). Terdapat perbedaan proporsi trauma hidung derajat 2 pada penggunaan nCPAP (14%) dibanding HHHFN (0%). Tidak terdapat perbedaan pH, pCO2, pO2 darah arteri, lama capaian minum enteral penuh, lama penggunaan alat, lama perawatan metode kanguru, dan insiden komplikasi (BPD, IVH, PDA, NEC dan SNAL) antara pengguna nCPAP dan HHHFN. HHHFN tidak lebih inferior ditinjau dari efektivitas dan keamanan dibanding nCPAP sebagai terapi non-invasif pada bayi pada bayi prematur usia > 28 minggu dan < 35 minggu dengan berat lahir > 1000 gram yang mengalami sesak napas derajat sedang jika diberikan sedini mungkin
Kata kunci: Prematur, nCPAP, HHHFN, sesak napas, uji non-inferioritas, efikasi dan efektivitas


Respiratory distress in new-borns are the most common morbidity in premature babies < 35 weeks. It should be treated immediately with positive airway pressure. Nasal CPAP is still the first choice of treatment for these cases. Despite its effectivity, nCPAP is proved causing nasal trauma as side effect. Meanwhile Heated Humidified high flow nasal cannula is an alternative oxygen therapy which also could generate inadvertent positive pressure airway, but the effectivity and safety has not been widely studied. The goal of this study is s identifying the effectivity and safety of HHHFN and nCPAP in premature babies ages > 28 weeks and < 35 weeks with moderate respiratory distress. This research is a random, non-inferiority, clinical trial which compares safety and effectivity between HHHFN and nCPAP in treating babies with moderate respiratory distress since in the delivery room. There is no difference in incidence of endotracheal intubation in < 72 hours of HHHFN (20%) compared to nCPAP 18% (p = 0,799). There is a significant difference of moderate nasal trauma in nCPAP (14%)compared to HHHFN (0%). There are no statistically differences of pH, pCO2, pO2 time to full enteral-feeding, length of Kangaroo Mother care, length of using the devices, and rate of in complication (BPD, IVH, PDA, NEC and SNAL)between nCPAP dan HHHFN user. HHHFN is not inferior than nCPAP in terms of safety and effectivity as primary noninvasive therapy in premature babies age > 28 weeks and < 35 weeks with moderate respiratory distress if given as early as possible.
Keywords: Premature, nCPAP, HHHFN, asphyxia, non-inferiority trial, safety, efficacy, and effectivity